Duties:

The CDA performs activities for assigned studies in support of DM study lead in compliance with company processes, GCP and regulations. Responsibilities may include editing and updating DM documents, conducting UAT testing, performing data review, discrepancy management, data reconciliation, data listing generation and distribution, tracking issues, performing database QC, and filing DM documents in the trial master file. Responsibilities (Essential Role Responsibilities):

• Facilitate updating DM Documents Data Management Plan (DMP), Data Validation Plan, Data Review Plan, CRF Completion Guidelines) per Lead DM expectations
• Verify external vendor test data per specifications document
• Run and review outputs and database study metrics
• Participate in data reviews
• Review discrepancies in EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines; note and communicate trends to clinical trial manager(s) for follow-up
• Reconcile external data to clinical study database and perform Serious Adverse Event reconciliation
• Ensure DM procedures and processes are adhered to in a consistent manner
• Provide high quality services through efficient and compliant processes

Skills:

Hands on experience with Electronic Data Capture systems (Medidata Rave desired) Excellent communication skills (verbal and written) Experienced working in a cross-functional team environment Strong organizational skills

Education:

Minimally 2 years of clinical data management experience in a biotech, pharmaceutical, or CRO environment is preferred Associates Degree or higher is required

Minimum Degree Required:

Associate's Degree (Community College, MBO)

Pay Range:

$45-51/hr

• based on experience